Registration Dossier

Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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biodegradation in water: simulation testing on ultimate degradation in surface water
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
According to REACH Annex IX (Degradation, biotic) column 2, further biotic degradation testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance and its degradation products. The choice of the appropriate test(s) depends on the results of the chemical safety assessment and may include simulation testing in appropriate media (e.g. water, sediment or soil). The registrant concludes that no testing is required out of the following reason:
The substance is manufactured as a feed additive only, no other uses were identified. Ethoxyquin as such is listed in the European Union Register of Feed Additives pursuant to Regulation (EC) No 1831/2003, on Annex I: List of additives (Released 19.09.2016, Edition 241), by the DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY, Directorate E - Food and feed safety, innovation, Unit E5 – Animal nutrition, veterinary medicines. As an approved feed additive, it is hence completely covered under the feed and food law and so not under the scope of REACH. Due to a change of the therein legally specified impurity profile, the substance as it is produced, does not fulfill these requirements any more, and is therefore, as a chemical substance not covered by other legislations, subject to REACH. After manufacture however, the substance will be directly purified to match the legal requirements for a feed additive. Hence, after purification the feed and food law will be applicable again, and the substance is no longer subject to REACH. Hence, only the very short service life of manufacture and transport needs to be regarded under REACH. During that period, sufficient precautions and safety measures are taken to avoid a release of the substance in the environment, so nearly no exposure of the environment to the substance is given and only negligible amounts are released, so only negligible amounts of the registered substance are contained in the waste water treated by the STP, there are no other ways that may lead to the exposure of the water compartment in general; liquid waste of the process is burned in a waste incineration unit. Prior to the emission into the STP, waste water is (pre)treated in a water-oil separator (two-phase system). Due to the high LogPow value of the substance, ethoxyquin (CAS 91-53-2) will be dissolved in the oil phase to a great extent and only negligible amounts are expected to stay in the water phase. Therefore, significant exposure of the substance into the water compartment can be excluded. As biotic degradation of the substance by environmental organisms (i.e. other species than humans) becomes really relevant only outside the applicability of and the substance’ subjection to REACH, testing for this endpoint is not relevant for the substance’ registration. The service life of the substance under REACH ends prior to the point of time where biotic degradation becomes relevant. Degradation of the substance in humans is sufficiently covered by IUCLID chapter 7.1.1, basic toxicokinetics.
Similar considerations apply to Sediment simulation testing: According to REACH Annex IX column 2, the study need not be conducted i.a. if direct and indirect exposure of sediment is unlikely. Only a negligible exposure of the environment to the substance is given during its service life under REACH.
According to ECHA’s „Guidance on information requirements and chemical safety assessment, Chapter R.5: Adaptation of information requirements“ of April 2010, „EXPOSURE BASED ADAPTATION AND TRIGGERING OF INFORMATION REQUIREMENTS … REACH provides for the option that information requirements may be adapted based on the justification… and that the likelihood of exposure to man or the environment is negligible.“ and „Terminology on adaptation: A variety of terms in relation to exposure based adaptations is used in column 2 of Annexes VIII-XI and in the revised Annex XI… The revised Annex XI( 3.2(c)), requires that “no release” should occur during the life cycle of substances incorporated into articles and that the “likelihood of exposure” to man and environment is “negligible” (= absence of exposure)“ and „Exposure based adaptations may be appropriate under the following conditions:
- exposure is absent (= exposure excluded) or not significant (= unlikely) throughout the life cycle of the substance for manufacture and all identified uses or
- when strictly controlled conditions apply throughout the life cycle of the substance for manufacture and all uses and
- no releases from the article life cycle stage (and subsequent waste life stage) is to be expected and consequently there is a negligible likelihood of exposure. Situation iii) only applies to substances incorporated into articles.“
Hence, the present exposure-based waiving is applicable also in the case of the release of an negligible amount, as the risk here in similarly controlled compared to “no release” and matches the wording of ECHA’s documents.

Data source

Materials and methods

Results and discussion

Transformation products:
not specified

Applicant's summary and conclusion